The National Association of Boards of Pharmacy (“NABP”), along with a coalition of healthcare stakeholders, recently announced collaborative steps to address prescription drug abuse and practitioner compliance with federal and state corresponding responsibility requirements while ensuring that patients receive needed medical care. Thirteen healthcare stakeholders, including NABP, the American Medical Association, Federation of State Medical Boards, National Association of Chain Drug Stores, Cardinal Health, CVS Caremark, Rite Aid and Walgreens met twice late last year to discuss these important, sometimes conflicting, issues. The stakeholders will issue a consensus document that identifies “red flags” or circumstances under which actions “should be initiated to ensure the legitimacy of a controlled substance prescription.” A second consensus document will provide industry guidelines concerning how to “engage in and improve the dialogue and collaboration among stakeholders” to address so-called red flags and to eliminate confusion caused by the “diversity of current proprietary policies.”

Much has been written about the Drug Enforcement Administration’s (“DEA’s”) recent focus away from non-legitimate prescribing by medical practitioners to an increased focus on dispensing pharmacists, drug manufacturers and distributors as controlled substance “gatekeepers” or “chokepoints” further up the distribution chain. The Agency has increasingly held these non-prescribers accountable for dispensing controlled substances pursuant to prescriptions not issued for a legitimate medical purpose. DEA regulations have long established that a corresponding responsibility rests with pharmacists to ensure that a prescription has been issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 21 C.F.R. § 1306.04(a). And, relying on the vague requirement that manufacturers and distributors design and operate a system to disclose to the registrant and report suspicious controlled substance orders (21 C.F.R. § 1301.74(b)), DEA has held them accountable for their pharmacy customers’ dispensing of controlled substances for other than legitimate medical purposes. DEA has taken administrative actions against, and U.S. attorneys’ offices have sought and obtained millions of dollars in civil penalties, from pharmacies, manufacturers and distributors for their alleged failure to comply with DEA regulations concerning controlled substance dispensing and distribution.

The collaborative efforts by the NABP and the healthcare stakeholders are a positive development for everyone. Clarifying prescription “red flags” and how stakeholders should communicate and collaborate with one another will benefit everyone, particularly patients in legitimate need of opioids and other controlled substances.